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Status:

TERMINATED

Trastuzumab With or Without Everolimus in Treating Women With Breast Cancer That Can Be Removed By Surgery

Lead Sponsor:

UNICANCER

Conditions:

Breast Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or...

Detailed Description

OBJECTIVES: Primary * To evaluate the added efficacy obtained by the association of trastuzumab (Herceptin®) with everolimus as preoperative therapy of primary HER2-positive breast cancer as shown b...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed diagnosis of invasive breast cancer
  • Previously untreated disease
  • Candidate for breast-conserving surgery, as defined by both of the following:
  • Clinical stage cT1-3, cN0-2 disease
  • Clinical stage M0 disease (bone scan, chest X-ray, and liver ultrasound required at screening to exclude metastatic disease)
  • HER2-positive primary tumor, defined as meeting either of the following criteria:
  • IHC 3+
  • IHC 2+ and FISH positive (centralized confirmation)
  • No inflammatory breast cancer or bilateral breast cancer
  • Patients who have been treated for cancer of the contralateral breast can be included if there is at least a 5 year time interval from last systemic treatment for breast cancer before randomization into this study
  • Hormone receptor status not specified
  • PATIENT CHARACTERISTICS:
  • WHO performance status 0-1
  • Menopausal status not specified
  • WBC ≥ 3.5 x 10\^9/L
  • ANC ≥ 1.5 x 10\^9/L
  • Platelet count ≥ 100 x 10\^9/L
  • Hb ≥ 10 g/dL
  • Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Serum transaminases activity ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min
  • FEV \> 55% by MUGA or ECHO
  • Spirometry and DLCO \> 50% of normal
  • O\_2 saturation \> 88% at rest on room air
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No known hypersensitivity to everolimus, sirolimus, trastuzumab (Herceptin®), or lactulose
  • No hypercholesterolemia/hypertriglyceridemia ≥ grade 3
  • No hypercholesterolemia/hypertriglyceridemia ≥ grade 2 with history of coronary artery disease (despite lipid-lowering treatment if given)
  • No uncontrolled infection
  • No other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, including any of the following:
  • Uncontrolled hypertension
  • Congestive cardiac failure
  • Ventricular arrhythmias
  • Active ischemic heart disease
  • Myocardial infarction within the past year
  • Chronic liver or renal disease
  • Active gastrointestinal tract ulceration
  • Severely impaired lung function
  • No known history of HIV seropositivity
  • No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • Willing to participate in the biological investigations
  • Not deprived of liberty or placed under guardianship
  • Patients must be affiliated to a Social Security System
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • More than 30 days (from the screening visit) since prior other investigational drugs
  • More than 5 days (from randomization) since prior and no concurrent strong inhibitors or inducers of the isoenzyme CYP3A, including any of the following
  • Rifabutin
  • Rifampicin
  • Clarithromycin
  • Ketoconazole
  • Itraconazole
  • Voriconazole
  • Ritonavir
  • Telithromycin
  • No other concurrent anti-cancer treatments such as chemotherapy, immunotherapy/biological response modifiers, endocrine therapy, or radiotherapy

Exclusion

    Key Trial Info

    Start Date :

    April 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    82 Patients enrolled

    Trial Details

    Trial ID

    NCT00674414

    Start Date

    April 1 2008

    Last Update

    January 18 2013

    Active Locations (8)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (8 locations)

    1

    Centre Oscar Lambret

    Lille, France, 59020

    2

    Centre Leon Berard

    Lyon, France, 69373

    3

    Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

    Marseille, France, 13273

    4

    Centre Regional Rene Gauducheau

    Nantes-Saint Herblain, France, 44805